A stable, ready to use, and consistent liquid treatment option for adult patients who have difficulty swallowing, or who cannot swallow tablets.
CaroSpir oral suspension ensures a stable and consistent dose every time. The complexities and inconsistencies of compounding are no longer an issue.
The CaroSpir oral suspension eliminates the need for additional preparation by the pharmacist or the patient.
CaroSpir is an FDA-approved oral suspension of spironolactone that does not contain a black box warning.
CaroSpir is indicated for the treatment of heart failure, hypertension, and edema caused by cirrhosis. For full indication, see below.
CaroSpir provides a stable and consistent treatment option for patients who have difficulty swallowing and are suffering from heart failure, edema caused by heart failure and cirrhosis, and hypertension. In clinical studies, other formulations of spironolactone have demonstrated significant mortality benefits and reduced the risk of hospitalization for cardiac causes.
CaroSpir does not carry a black box warning.
CaroSpir will be introduced early in the fourth quarter of 2017. Check this website for updates.
CaroSpir is not therapeutically equivalent to Aldactone tablets. For an equivalent dose, CaroSpir results in 15 to 37% higher serum concentration compared to Aldactone tablets. A high fat and high calorie meal (57% of the ~1000 kcal of the meal were from fat) increased the bioavailability of spironolactone (as measured by AUC) by approximately 90%. Patients should establish a routine pattern for taking CAROSPIR with regard to meals. See Prescribing Information for important dosage information.
CAROSPIR is an antagonist of aldosterone indicated for:
CAROSPIR is contraindicated for patients with the following conditions:
CAROSPIR may cause the following conditions.
The most common adverse reaction (incidence > 5%) with CAROSPIR treatment is the increased occurrence of gynecomastia in men.
Talk to your healthcare provider about other possible side effects with CAROSPIR. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, INC. at 1-844-321-1443 , or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
CAROSPIR oral suspension, 25 mg/5 mL, is not therapeutically equivalent to tablet forms of spironolactone. Follow dosing instructions for CAROSPIR. In patients requiring a dose greater than 100 mg, use another formulation of spironolactone. Doses of CAROSPIR suspension greater than 100 mg may result in spironolactone concentrations higher than expected.
Please see Prescribing Information for additional safety information.
CAROSPIR is an antagonist of aldosterone indicated for: the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure; use as an add-on therapy for the treatment of hypertension, to lower blood pressure; the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions.
CAROSPIR is contraindicated for patients with the following conditions: hyperkalemia; Addison’s disease; concomitant use of eplerenone.